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Trial registered on ANZCTR


Registration number
ACTRN12625000178448p
Ethics application status
Submitted, not yet approved
Date submitted
29/01/2025
Date registered
14/02/2025
Date last updated
14/02/2025
Date data sharing statement initially provided
14/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
An open label pilot study of 30% sodium asCOrbate aS OSMOtherapy in patientS with traumatic brain injury and raised intracranial pressure- The COSMOS study
Scientific title
An open label pilot feasibility study of 30% sodium asCOrbate aS OSMOtherapy in patientS with traumatic brain injury and raised intracranial pressure
Secondary ID [1] 313838 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
traumatic brain injury 336486 0
traumatic intracranial hypertension 336487 0
Condition category
Condition code
Neurological 332998 332998 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Enrolled participants will become eligible for delivery of the intervention if the intracranial pressure (ICP) is equal or more 20 mmHg for 5 minutes despite adequate sedation, positioning, and physiological optimisation and/or the treating clinicians believe that it is necessary to provide immediate treatment for raised ICP.

Dosing regimen
A 60 ml of neat 30% sodium ascorbate (18 grams) will be infused through a dedicated lumen of a central venous catheter over 10 minutes. If the ICP remains equal or above 20 mmHg for more 5 minutes 60 minutes post the first dose, a second bolus dose of 40 mL of neat 30% sodium ascorbate (12 grams) will be infused through a dedicated lumen of a central venous catheter over 10 minutes.
Patients will only receive sodium ascorbate once during their ICU admission if their ICP increases above 20 mmHg. The duration of administration is maximum of 20 minutes. Any staff providing the intervention (Either ICU nurse or the treating physician) will receive protocol training. Intervention administration will be recorded in the medical records and used to monitor protocol adherence.
Intervention code [1] 330422 0
Treatment: Drugs
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340538 0
Feasibility
Timepoint [1] 340538 0
ICU admission
Secondary outcome [1] 444387 0
Feasibility
Timepoint [1] 444387 0
At the end of recruitment period

Eligibility
Key inclusion criteria
Adult patients (age 18 years or above) with moderate to severe TBI
Insertion of invasive neuromonitoring as per the treating clinical team
Potential to require osmotherapy for the management of intracranial hypertension.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Admission to the ICU is solely for the purposes of palliative care or confirmation of organ donation
Advanced care directive or previously stated wish not to be included in research activities
Bilateral fixed and dilated pupils and/or deemed to be non-survivable by treating clinical team
Pre-existing end stage renal failure, Child B or C liver disease,
Known G6PD deficiency or G6PD positivity on BinaxNOWTM G6PD Point-of-Care Qualitative Rapid Diagnostic Test (Lake Forest, Illinois, USA)
Plasma sodium > 150 mmol/L
Plasma sodium < 130 mmol/L
eGFR < 30 mL/min/1.73m2
Type 1 diabetes mellitus
History of ketoacidosis
Use of SGLT2 Inhibitors
Sickle cell disease
Confirmed or suspected pregnancy
History of oxalate renal stones

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
3/03/2026
Actual
Date of last data collection
Anticipated
27/03/2026
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC

Funding & Sponsors
Funding source category [1] 318309 0
Other
Name [1] 318309 0
GSK Award for Research Excellence
Country [1] 318309 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 320695 0
None
Name [1] 320695 0
NA
Address [1] 320695 0
Country [1] 320695 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316944 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316944 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 316944 0
Australia
Date submitted for ethics approval [1] 316944 0
05/02/2025
Approval date [1] 316944 0
Ethics approval number [1] 316944 0

Summary
Brief summary
The goal of COSMOS is to conduct an open label feasibility study of hypertonic sodium ascorbate for the management of intracranial hypertension in traumatic brain injury
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139514 0
Prof Andrew Udy
Address 139514 0
Monash University, 553 St Kilda Road, Melbourne, VIC, 3004
Country 139514 0
Australia
Phone 139514 0
+61 438 755 568
Fax 139514 0
Email 139514 0
[email protected]
Contact person for public queries
Name 139515 0
Camila Battistuzzo
Address 139515 0
Monash University, 553 St Kilda Road, Melbourne, VIC, 3004
Country 139515 0
Australia
Phone 139515 0
+61 3 9903 0343
Fax 139515 0
Email 139515 0
[email protected]
Contact person for scientific queries
Name 139516 0
Mark Plummer
Address 139516 0
Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
Country 139516 0
Australia
Phone 139516 0
+61 0870740000
Fax 139516 0
Email 139516 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.